Breast Cancer
Conditions
Brief summary
This is a descriptive, prospective, observational and epidemiological study on participants recently diagnosed with breast cancer to evaluate the HER2 status by IHC and SISH procedures.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Anatomopathological samples (surgical specimens or when a surgical sample is not possible, a core needle biopsy may be used) from female participants with a histopathological diagnosis of invasive breast cancer
Exclusion criteria
* Samples whose residual material in the paraffin block(s) is insufficient for neoplasm representation in the procedures in this study * Cancer samples that have received previous chemotherapy treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures | Baseline up to 30 months | HER2 status of the collected tissue samples was determined based on the results obtained from IHC test and SISH procedure. The IHC test gives a score of 0 to 3 positive (+) that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called HER2 negative (-). If the score is 2+, it's called borderline. A score of 3+ is called HER2 positive. Tissue samples which had the IHC score of 2+ (borderline) were re-tested using SISH procedure for confirmation of the HER2 status. Tissue samples with SISH test results + were considered as HER2+. Tissue samples for which HER2 status was not determined were considered as HER2 equivocal. |
| Percentage of Participants With Different Phenotypes of Breast Cancer | Baseline up to 30 months | Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were estrogen receptor (ER) + and/or progesterone receptor (PR) +, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Histological grading was done by Nottingham Histologic Score system based on three factors, a) the amount of gland formation (differentiation), b) the nuclear features (pleomorphism) and c) the mitotic activity. Each of these features is scored from 1-3, and then each score is added to give a final total score ranging from 3-9. The final total score is used to determine the grade in the following way: i) Grade 1 tumors have a score of 3-5, ii) Grade 2 tumors have a score of 6-7, and iii) Grade 3 tumors have a score of 8-9. |
| Percentage of Participants With Histological Sub-types of Breast Cancer | Baseline up to 30 months | Histological subtypes of breast cancer included ductal carcinoma, lobular carcinoma, mucinous carcinoma, mixed carcinoma, metaplastic carcinoma, and others. |
| Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups | Baseline up to 30 months | Participants were categorized in to following age groups: a) less than (\<) 40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) greater than or equal to (≥) 70 years. |
| Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades | Baseline up to 30 months | Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms. |
| Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion | Baseline up to 30 months | Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels. |
| Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups | Baseline up to 30 months | Participants were categorized in to following age groups: a) \<40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years. |
| Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades | Baseline up to 30 months | Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms. |
| Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion | Baseline up to 30 months | Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels. |
| Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups | Baseline up to 30 months | Participants were categorized in to following age groups: a) \<40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years. |
| Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades | Baseline up to 30 months | Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms. |
| Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion | Baseline up to 30 months | Lymphovascular invasion is entering of breast cancer cells in to the lymph or blood/vascular channels. |
| Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | Baseline up to 30 months | Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Participants were categorized in to following age groups: a) \<40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years. |
| Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades | Baseline up to 30 months | Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms. |
| Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion | Baseline up to 30 months | Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels. |
| Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status | Baseline up to 30 months | Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. |
| Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status | Baseline up to 30 months | Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. |
| Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status | Baseline up to 30 months | Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. |
| Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries | Baseline up to 30 months | Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. |
Countries
Peru, Uruguay
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Breast Cancer Participants Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study. | 580 |
| Total | 580 |
Baseline characteristics
| Characteristic | Breast Cancer Participants |
|---|---|
| Age, Continuous | 58 years |
| Sex: Female, Male Female | 580 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
Time frame: Baseline up to 30 months
Population: Included all breast cancer tissue samples for which the phenotype was identified.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Breast Cancer Participants | Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries | 31.9 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries | 35.0 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries | 12.1 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries | 20.9 percentage of participants |
Primary
Percentage of Participants With Different Phenotypes of Breast Cancer
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were estrogen receptor (ER) + and/or progesterone receptor (PR) +, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Histological grading was done by Nottingham Histologic Score system based on three factors, a) the amount of gland formation (differentiation), b) the nuclear features (pleomorphism) and c) the mitotic activity. Each of these features is scored from 1-3, and then each score is added to give a final total score ranging from 3-9. The final total score is used to determine the grade in the following way: i) Grade 1 tumors have a score of 3-5, ii) Grade 2 tumors have a score of 6-7, and iii) Grade 3 tumors have a score of 8-9.
Time frame: Baseline up to 30 months
Population: Included all breast cancer tissue samples for which the phenotype could be identified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer | Luminal A | 31.9 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer | Luminal B | 35 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer | Triple Negative | 20.9 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer | HER2 Enriched | 12.1 percentage of participants |
Primary
Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Participants were categorized in to following age groups: a) \<40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.
Time frame: Baseline up to 30 months
Population: Included all breast cancer tissue samples for which the phenotype was identified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | ≥70 years | 30.6 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | 50-59 years | 19.1 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | <40 years | 3.3 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | 60-69 years | 25.1 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | 40-49 years | 21.9 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | 60-69 years | 23.4 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | ≥70 years | 15.4 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | <40 years | 10.4 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | 50-59 years | 28.9 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | 40-49 years | 21.9 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | 60-69 years | 20 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | 40-49 years | 18.6 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | 50-59 years | 38.6 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | ≥70 years | 12.9 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | <40 years | 10 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | ≥70 years | 22.5 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | 50-59 years | 25.8 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | 40-49 years | 20 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | 60-69 years | 25 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups | <40 years | 6.7 percentage of participants |
Comparison: Breast cancer phenotypes association with age groups.p-value: =0.003ANOVA
Primary
Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
Time frame: Baseline up to 30 months
Population: Included all breast cancer tissue samples for which the phenotype was identified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status | ER Status: Positive | 97.8 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status | ER Status: Negative | 2.2 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status | ER Status: Negative | 4 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status | ER Status: Positive | 96 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status | ER Status: Positive | 0 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status | ER Status: Negative | 100 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status | ER Status: Positive | 0 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status | ER Status: Negative | 100 percentage of participants |
Comparison: phenotypes of breast cancer association with ER status.p-value: <0.001ANOVA
Primary
Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
Time frame: Baseline up to 30 months
Population: Included all breast cancer tissue samples for which the phenotype was identified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status | HER2 Status: Positive | 0 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status | HER2 Status: Negative | 100 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status | HER2 Status: Negative | 77.6 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status | HER2 Status: Positive | 22.4 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status | HER2 Status: Positive | 100 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status | HER2 Status: Negative | 0 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status | HER2 Status: Positive | 0 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status | HER2 Status: Negative | 100 percentage of participants |
Comparison: phenotypes of breast cancer association with HER2 status.p-value: <0.001ANOVA
Primary
Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.
Time frame: Baseline up to 30 months
Population: Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion | Absent | 33 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion | Present | 67 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion | Present | 56.7 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion | Absent | 43.3 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion | Present | 54.3 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion | Absent | 45.7 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion | Absent | 24.2 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion | Present | 75.8 percentage of participants |
Comparison: phenotypes of breast cancer association with lymphovascular invasion.p-value: =0.001ANOVA
Primary
Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.
Time frame: Baseline up to 30 months
Population: Included all breast cancer tissue samples for which the phenotype was identified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades | Nuclear grade 2 | 80.9 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades | Nuclear grade 1 | 5.5 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades | Nuclear grade 3 | 13.7 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades | Nuclear grade 3 | 30.8 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades | Nuclear grade 1 | 4.0 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades | Nuclear grade 2 | 65.2 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades | Nuclear grade 2 | 25.7 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades | Nuclear grade 3 | 74.3 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades | Nuclear grade 1 | 0 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades | Nuclear grade 2 | 31.7 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades | Nuclear grade 3 | 68.3 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades | Nuclear grade 1 | 0 percentage of participants |
Comparison: Breast cancer phenotypes association with nuclear grades.p-value: <0.001ANOVA
Primary
Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
Time frame: Baseline up to 30 months
Population: Included all breast cancer tissue samples for which the phenotype was identified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status | PR Status: Positive | 72.1 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status | PR Status: Negative | 27.9 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status | PR Status: Negative | 23.4 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status | PR Status: Positive | 76.6 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status | PR Status: Positive | 0 percentage of participants |
| BC Participants-HER2 Enriched Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status | PR Status: Negative | 100 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status | PR Status: Positive | 0 percentage of participants |
| BC Participants-Triple Negative Phenotype | Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status | PR Status: Negative | 100 percentage of participants |
Comparison: Phenotypes of breast cancer association with PR status.p-value: <0.001ANOVA
Primary
Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups
Participants were categorized in to following age groups: a) less than (\<) 40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) greater than or equal to (≥) 70 years.
Time frame: Baseline up to 30 months
Population: Included breast cancer tissue samples from all participants who were willing to participate in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups | <40 years | 9.4 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups | 40-49 years | 19.7 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups | 60-69 years | 22.7 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups | ≥70 years | 18.2 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups | 50-59 years | 30.0 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups | 60-69 years | 24.4 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups | <40 years | 6.4 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups | 40-49 years | 21.8 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups | 50-59 years | 24.4 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups | ≥70 years | 23.1 percentage of participants |
Comparison: ER status association with age groupsp-value: 0.28Chi-squared
Primary
Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion
Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.
Time frame: Baseline up to 30 months
Population: Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion | Present | 69.5 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion | Absent | 30.5 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion | Present | 60.1 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion | Absent | 39.9 percentage of participants |
Comparison: ER status association with lymphovascular invasion.p-value: =0.03Chi-squared
Primary
Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades
Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.
Time frame: Baseline up to 30 months
Population: Included breast cancer tissue samples from all participants who were willing to participate in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 1 | 0 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 2 | 30 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 3 | 70 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 1 | 4.8 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 2 | 74 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 3 | 21.2 percentage of participants |
Comparison: ER status association with nuclear grade.p-value: <0.001Chi-squared
Primary
Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups
Participants were categorized in to following age groups: a) \<40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.
Time frame: Baseline up to 30 months
Population: Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups | 40-49 years | 21.8 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups | 60-69 years | 23.7 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups | 50-59 years | 23.7 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups | ≥70 years | 24.0 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups | <40 years | 6.8 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups | ≥70 years | 11.3 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups | <40 years | 9.6 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups | 40-49 years | 18.3 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups | 50-59 years | 36.5 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups | 60-69 years | 24.3 percentage of participants |
Comparison: HER2 status association with age groups.p-value: =0.056ANOVA
Primary
Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion
Lymphovascular invasion is entering of breast cancer cells in to the lymph or blood/vascular channels.
Time frame: Baseline up to 30 months
Population: Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion | Present | 65.3 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion | Absent | 34.7 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion | Present | 57.4 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion | Absent | 42.6 percentage of participants |
p-value: =0.129Chi-squared
Primary
Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades
Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.
Time frame: Baseline up to 30 months
Population: Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 1 | 3.9 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 2 | 62.5 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 3 | 33.6 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 1 | 0 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 2 | 41.7 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 3 | 58.3 percentage of participants |
Comparison: HER2 status association with nuclear grade.p-value: <0.001Chi-squared
Primary
Percentage of Participants With Histological Sub-types of Breast Cancer
Histological subtypes of breast cancer included ductal carcinoma, lobular carcinoma, mucinous carcinoma, mixed carcinoma, metaplastic carcinoma, and others.
Time frame: Baseline up to 30 months
Population: Included breast cancer tissue samples from all participants who were willing to participate in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With Histological Sub-types of Breast Cancer | Ductal carcinoma | 78.3 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Histological Sub-types of Breast Cancer | Lobular carcinoma | 10.9 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Histological Sub-types of Breast Cancer | Mucinous carcinoma | 3.6 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Histological Sub-types of Breast Cancer | Mixed carcinoma | 1.2 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Histological Sub-types of Breast Cancer | Metaplastic carcinoma | 1.2 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Histological Sub-types of Breast Cancer | Others | 4.8 percentage of participants |
Primary
Percentage of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures
HER2 status of the collected tissue samples was determined based on the results obtained from IHC test and SISH procedure. The IHC test gives a score of 0 to 3 positive (+) that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called HER2 negative (-). If the score is 2+, it's called borderline. A score of 3+ is called HER2 positive. Tissue samples which had the IHC score of 2+ (borderline) were re-tested using SISH procedure for confirmation of the HER2 status. Tissue samples with SISH test results + were considered as HER2+. Tissue samples for which HER2 status was not determined were considered as HER2 equivocal.
Time frame: Baseline up to 30 months
Population: Included breast cancer tissue samples from all participants who were willing to participate in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures | HER2 negative | 79.1 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures | HER2 positive | 19.8 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures | HER2 equivocal | 1 percentage of participants |
Primary
Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups
Participants were categorized in to following age groups: a) \<40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.
Time frame: Baseline up to 30 months
Population: Included breast cancer tissue samples from all participants who were willing to participate in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups | 40-49 years | 15.9 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups | 60-69 years | 26.6 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups | 50-59 years | 30.7 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups | ≥70 years | 21.0 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups | <40 years | 5.9 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups | ≥70 years | 21.7 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups | <40 years | 9.0 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups | 40-49 years | 26.2 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups | 50-59 years | 22.1 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups | 60-69 years | 21.0 percentage of participants |
Comparison: PR status association with age groupsp-value: =0.004Chi-squared
Primary
Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion
Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.
Time frame: Baseline up to 30 months
Population: Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion | Present | 67.9 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion | Absent | 32.1 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion | Present | 58.8 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion | Absent | 41.2 percentage of participants |
Comparison: PR status association with lymphovascular invasion.p-value: =0.025ANOVA
Primary
Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades
Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.
Time frame: Baseline up to 30 months
Population: Included breast cancer tissue samples from all participants who were willing to participate in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast Cancer Participants | Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 1 | 2.1 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 2 | 44.5 percentage of participants |
| Breast Cancer Participants | Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 3 | 53.4 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 1 | 2.1 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 3 | 23.1 percentage of participants |
| Breast Cancer Participants (ER+) | Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades | Nuclear grade 2 | 72.8 percentage of participants |
Comparison: PR status association with nuclear grade.p-value: <0.001Chi-squared